Diabetes Mellitus Type 1 Clinical Trial
Official title:
The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor,
cells will be passaged to passage 5.
Before release the sample will be subject to our release criteria which include: testing for
any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be
negative. In addition the cell count and viability (must be more than 80%) are done before
release. Surface markers documentation is done on the cells before release using flow
cytometry.
The cells should be infused within 2 hours of release. The dose to is to be repeated after 6
months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24
and 36 when the study is stopped.
These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes
Mellitus.
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